CART-PSMA Cells for Advanced Prostate Cancer

Part A (Dose Escalation) + Part B (Expansion Cohort) total up to 20 patients enrolled.

Inclusion criteria

• All participants must have the ability to understand and the willingness to sign a written informed consent.
• Histologic confirmation of prostate cancer.
• Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
• Under general air conditions, blood oxygen saturation >90%.
• Adequate liver function, specifically alanine aminotransferase (ALT) < 3 times of upper limit of normal (ULN), aspartate transferase (AST)< 3 times of ULN, serum bilirubin and alkaline phosphatase < 2 times of ULN.
• Adequate renal function, specifically serum creatinine < 2.0 mg/dl.
• Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.
• Hemoglobin concentration ≥80g/L.
• The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.

Exclusion criteria

• Patients with other malignant tumors or major diseases.
• Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
• Patients with uncontrolled active infection.
• Patients with active hepatitis B or hepatitis C infection.
• Patients with human immunodeficiency virus (HIV) infection.
• Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
• Patients with various types of serious heart disease or a history of severe cerebrovascular disease.
• Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.
• Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.
• Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.